SCM Lifescience has failed to prove the efficacy of its acute pancreatic treatment candidate in the domestic phase 1/2a clinical trial. Moreover, the company revised the disclosure of clinical results on the same day, causing stirs, according to industry sources.
In a public notice on Wednesday, SCM Lifescience said it had failed to satisfy the primary effectiveness assessment index in the SCM-AGH 1/2a clinical trial on patients with acute pancreatic inflammation of moderate or higher levels.
The company set its primary effectiveness evaluation variables as “CTSI (Computerized Tomography Severity Index) on the 28th day of administering treatment for clinical trial and MMS (Modified Marshall Score) change on the seventh day of administering drugs but failed to confirm statistical significance in the testing group against placebo group in both indexes.
“However, there have been no grave adverse drug reactions that can affect safety, embolization-related abnormal reactions, or adverse drug reactions resulting in subjects’ halfway dropouts during phase 1 and 2a trial periods,” the company said.
SCM Lifescience added that there were no cases of subjects who died during the clinical trial period related to SCM-AHG.
Concerning the disclosure of the results of 1/2a trial results, the company also revised part of the contents on the day of issuing its public notice.
In the revision, SCM Lifescience played down the contents regarding the primary effectiveness evaluation index while stressing the secondary effectiveness assessment index.
For example, the company deleted the sentence, “There was a statistically significant reduction in CTSI points (CTSI p=0.0078) before and after administering the trial drug within the test drug-administered group.” Instead, it inserted a new sentence, “Both the primary and secondary effectiveness evaluation indexes are parallel indexes and primary endpoints.”
In addition, the company stressed it confirmed that among secondary effectiveness assessment indexes, the “CPR (C-Reactive Protein) number showed a statistically significant reduction in the trial group compared to the placebo group.
Despite its failure in attaining the primary endpoint indexes, SCM Lifescience said it “expects the immunity-controlling mechanism of SCM-AGH to effectively work in the early treatment of acute pancreatic inflammation,” drawing attention to its future development plans and market reaction, the industry watchers said.
SCM Lifesicence won the approval for SCM-AGH 1/2a investigational new drug (IND) clinical trials from the Ministry of Food and Drug Safety in 2018 and conducted clinical trials at 11 domestic medical institutions before completing them on March 15.